tacrolimus and prednisolone-acetate

The purpose of this study was to evaluate for the first time the efficacy and safety of topical FK506 in patients undergoing penetrating normal-risk keratoplasty in a prospectively randomized clinical trial. Twenty patients were treated with FK506 0.06% three times per day for 6 months postoperatively. An additional 20 patients received five drops of prednisolone acetate 1% tapered within 6 months. All patients received 1 mg/kg bodyweight/day of systemic fluocortolon tapered within 3 weeks postoperatively. Clear graft survival, ratio of immune reactions and side effects were the main outcome measures. One year postoperatively all patients of the FK 506 group were free from immune reactions, in contrast to 84% in the steroid group (Kaplan-Meier values; P = 0.9 in the log rank test). None of the patients developed irreversible graft failure so far. In eight patients of the FK506 group premature withdrawal of the drug was deemed appropriate because of local side effects. FK506 might turn out to become an effective immunoprophylaxis in subjects undergoing penetrating normal-risk keratoplasty. Local discomfort should be further reduced.

Topics: Adult; Aged; Aged, 80 and over; Female; Fluocortolone; Graft Survival; Humans; Immunosuppressive Agents; Keratoplasty, Penetrating; Male; Middle Aged; Ophthalmic Solutions; Pilot Projects; Prednisolone; Prospective Studies; Tacrolimus; Transplantation, Homologous

To investigate the effectiveness of topical tacrolimus treatment on herpetic stromal keratitis (HSK) in a rat model.. The development of HSK was monitored for 14 days after the inoculation of rats with herpes simplex type 1 virus. Rats that developed HSK were divided into four groups as follows: (1) topical antiviral treatment (control), (2) topical antiviral and 1% prednisolone acetate, (3) topical antiviral and 0.03% tacrolimus ointment, and (4) topical antiviral plus 0.1% tacrolimus ointment. After 14 days of treatment, the severity levels of HSK were scored and compared with the levels before the treatment. The expression of CD3, CD4, and CD8 was evaluated by flow cytometry. The development of the disease was evaluated clinically and histologically.. Significant improvement in vascularization was observed in the groups with the drug treatment in addition to the antiviral agent (P<0.05), but there was no obvious difference within groups 2, 3, and 4 in the vascularization severity. The regression of corneal edema was 8.05%±6% in group 1, 25.17%±14.55% in group 2 (P=0.01), 36.40%±21.69% in group 3 (P=0.03), and 46.39%±14.96% in group 4 (P=0.00). A significant decrease in the number of inflammatory cells in the groups with the drug treatment was evaluated by immunohistochemical staining and confirmed by flow cytometry analysis.. Topical tacrolimus treatment caused a significant decrease in corneal vascularization accompanied by a lower number of inflammatory cells in the experimental HSK corneal edema model. Therefore, topical tacrolimus has the potential to be used in the treatment of HSK.

Topics: Administration, Topical; Animals; CD3 Complex; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Corneal Diseases; Corneal Stroma; Disease Models, Animal; Eye Infections, Viral; Flow Cytometry; Glucocorticoids; Herpesvirus 1, Human; Immunosuppressive Agents; Keratitis, Herpetic; Ophthalmic Solutions; Prednisolone; Prospective Studies; Rats; Rats, Wistar; Tacrolimus

To evaluate the long-term effectiveness of the combination of topical cyclosporine drops and tacrolimus ointment in the treatment of steroid-dependent atopic keratoconjunctivitis (AKC).. Ten patients with moderate to severe AKC participated in the study. Topical cyclosporine 0.05% was used, as a monotherapy, 6 times daily during the first month of the study, followed by 4 times daily during the second month. The patients were then instructed to self-treat with topical cyclosporine at a dose ranging from 2 to 6 times daily depending on the severity of the disease. Tacrolimus ointment 0.03% was applied on the lid skin. Follow-up examinations were performed approximately every 3 months. Each patient completed a follow-up period of at least 12 months. Symptoms and signs of AKC were assessed on the day of enrollment, on days 28, 56, and 63, and at subsequent follow-up visits. Flare-ups of AKC requiring steroid use and progression of the disease findings were also recorded.. All patients experienced significant improvement of their symptoms and signs during the first 2 months of the study. Two patients were lost to follow-up after the initial 2 months. One patient was noncompliant and continued the treatment only for 7 months. During the median treatment period of 21.5 months for the 7 continuing patients, a total of only 2 flare-up episodes were noted requiring topical steroids.. Adequate topical immunomodulation using topical calcineurin inhibitors may eliminate the need for steroids and favorably alter the long-term prognosis of patients with AKC.

Topics: Administration, Topical; Adult; Calcineurin Inhibitors; Conjunctivitis, Allergic; Cyclosporine; Drug Therapy, Combination; Enzyme Inhibitors; Female; Glucocorticoids; Humans; Immunosuppressive Agents; Male; Middle Aged; Ointments; Ophthalmic Solutions; Prednisolone; Prospective Studies; Tacrolimus; Treatment Outcome; Visual Acuity; Young Adult